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National Statement on Ethical Conduct in Human Research 2007 Human biospecimens submission

ID: 
36
This submission reflects the views of
Organisation Name: 
Queensland Health- Chief Health Officer Branch
Personal Details
Additional Information
Please identify the best term to describe the Organisation: 
Government Department – State / Territory
Specific Comments
Comments: 
Prospective collection of human biospecimens for research – paragraphs 3.4.1 – 3.4.4

3.4.4a should include additional assurance to HRECs that consent for future extended or unspecified research on the donated biospecimen, is ethically acceptable and consistent with Chapter 2.2:General Requirements for consent. This has been a frequently raised concern by Queensland HRECs.

 

Use of human biospecimens obtained after death – paragraph 3.4.5

should be amended to State Legislation

Ethical review before human biospecimens are used in research – paragraphs 3.4.6 – 3.4.11

3.4.7 The draft needs to reinforce that biobanks have policies that ensure biospecimens, stored for potential diagnostic purpose are not exhausted by research utilisation. A corollary is that there should be reflection on the use samples taken for research purposes and their potential diagnostic use.

Ethical review before human biospecimens are used in research – paragraphs 3.4.6 – 3.4.11

3.4.11 The draft advice should be amended to instruct the researcher to determine if State legislation regulates release of patient confidential information or data collected from tissues when the requirement of consent is waived.

General Comments
Comments: 

There is insufficient guidance of disposal of samples in the revised version.  The current version 3.4.1 (c) and 3.4.3 refers to institutional policy guiding the disposal of samples.

Page reviewed: 3 June, 2013